Division of Oncology, S. Orsola-Malpighi Hospital, Bologna, Italy.
Department of Medical Oncology, Azienda USL - IRCCS Institute of Neurological Sciences, Bologna, Italy.
Clin Genitourin Cancer. 2021 Feb;19(1):32-40. doi: 10.1016/j.clgc.2020.06.003. Epub 2020 Jun 27.
The International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) criteria have been largely adopted in clinical practice. In a recent retrospective study, we assessed that the addition of the first site of metastatic disease to brain, bone, and liver improves prognostic stratification of patients with metastatic renal cell carcinoma (mRCC). Here, we performed an external validation in patients with mRCC. Our aim was to evaluate if the addition of a new independent variable could improve IMDC prognosis prediction and reduce heterogeneity within risk categories.
We selected all 1073 patients treated at a single institution for mRCC and included in the Institute Gustave Roussy Renal Cell Carcinoma database. All patients included received at least 1 line of targeted therapy or immune checkpoint inhibitors. Univariate and multivariate analyses (Cox regression model) were performed. Bootstrap validation of the final model was also carried out for internal validation. The IMDC modified classification was defined by the addition of the seventh variable, and we defined the modified IMDC good-risk criteria as 0 risks, intermediate-risk as 1 to 2 risks, and poor-risk as 3 or more risks.
The presence of brain, bone, and/or liver as the first site of metastatic disease plus the other variables included in the IMDC score were statistically significant variables associated with overall survival (OS) after univariate and multivariate analysis and bootstrap validation. Finally, 122 (15%) patients had a modification of their initial risk category. The median OS in the poor-, intermediate-, and favorable-risk groups was 10, 26, and 52 months, respectively (P < .001). The bias-corrected concordance index in patients receiving immune checkpoint inhibitors (n = 241) was 0.71.
The addition of brain, bone, and/or liver metastases as an additional variable to the other IMDC variables improves the prognostic predictive power of the model.
国际转移性肾细胞癌数据库联盟（IMDC）标准已在临床实践中得到广泛应用。在最近的一项回顾性研究中，我们评估了将转移性疾病的第一个部位（脑、骨和肝）添加到脑、骨和肝中可改善转移性肾细胞癌（mRCC）患者的预后分层。在这里，我们在 mRCC 患者中进行了外部验证。我们的目的是评估添加新的独立变量是否可以改善 IMDC 预后预测并降低风险类别的异质性。
我们选择了在单一机构接受 mRCC 治疗并纳入 Gustave Roussy 研究所肾细胞癌数据库的 1073 名患者。所有纳入的患者均接受了至少一线靶向治疗或免疫检查点抑制剂治疗。进行了单变量和多变量分析（Cox 回归模型）。还对最终模型进行了 Bootstrap 验证，以进行内部验证。IMDC 改良分类由第七个变量定义，我们将改良的 IMDC 低危标准定义为 0 个风险，中危为 1 到 2 个风险，高危为 3 个或更多风险。
脑、骨和/或肝作为转移疾病的第一个部位加上 IMDC 评分中包含的其他变量是与单变量和多变量分析以及 Bootstrap 验证后总生存（OS）相关的统计学显著变量。最终，122 名（15%）患者改变了初始风险类别。在低危、中危和低危组中，中位 OS 分别为 10、26 和 52 个月，差异具有统计学意义（P<.001）。接受免疫检查点抑制剂治疗的患者（n=241）的校正后一致性指数为 0.71。
将脑、骨和/或肝转移作为其他 IMDC 变量的附加变量添加可提高模型的预后预测能力。
